UMOYA: a prospective longitudinal cohort study to evaluate novel diagnostic tools and to assess long-term impact on lung health in South African children with presumptive pulmonary TB-a study protocol

• Published in: BMC pulmonary medicine 2023-03, Vol.23 (1), p.97-11, Article 97
• Main Authors: Dewandel, Isabelle, van Niekerk, Margaret, Ghimenton-Walters, Elisabetta, Palmer, Megan, Anthony, Michaile G, McKenzie, Carla, Croucamp, Rolanda, Alter, Galit, Demers, Anne-Marie, van Zyl, Gert, Claassen, Mathilda, Goussard, Pierre, Swanepoel, Ruan, Hoddinott, Graeme, Bosch, Corne, Dunbar, Rory, Allwood, Brian, McCollum, Eric D, Schaaf, H Simon, Hesseling, Anneke C, van der Zalm, Marieke M
• Format: Article
• Language: English
• Subjects: Age; Algorithms; Biomarkers; Biorepository; Child; Children; Children & youth; Cohort analysis; Coronaviruses; COVID-19; Diagnosis; Diagnostic tests; Disease transmission; Diseases; HIV; Human immunodeficiency virus; Humans; Illnesses; Infections; Investigations; Laboratories; Longitudinal Studies; Lung - diagnostic imaging; Lung function; Lung health; Lungs; Mycobacterium tuberculosis; Observational Studies as Topic; Paediatric pulmonary tuberculosis; Pediatrics; Post-TB health; Prospective Studies; Pulmonology; Quality of Life; Respiratory diseases; Respiratory function; Retrospective Studies; Risk factors; South Africa; Sputum; Study Protocol; Tuberculosis; Tuberculosis, Pulmonary - diagnosis; Tuberculosis, Pulmonary - drug therapy
• ISSN: 1471-2466; 1471-2466
• DOI: 10.1186/s12890-023-02329-3

Despite a high paediatric tuberculosis (TB) burden globally, sensitive and specific diagnostic tools are lacking. In addition, no data exist on the impact of pulmonary TB on long-term child lung health in low- and middle-income countries. The prospective observational UMOYA study aims (1) to build a state-of-the-art clinical, radiological, and biological repository of well-characterised children with presumptive pulmonary TB as a platform for future studies to explore new emerging diagnostic tools and biomarkers for early diagnosis and treatment response; and (2) to investigate the short and long-term impact of pulmonary TB on lung health and quality of life in children. We will recruit up to 600 children (0-13 years) with presumptive pulmonary TB and 100 healthy controls. Recruitment started in November 2017 and is expected to continue until May 2023. Sputum and non-sputum-based samples are collected at enrolment and during follow-up in TB cases and symptomatic controls. TB treatment is started by routine care services. Intensive follow-up for 6 months will allow for TB cases to retrospectively be classified according to international consensus clinical case definitions for TB. Long-term follow-up, including imaging, comprehensive assessment of lung function and quality of life questionnaires, are done yearly up to 4 years after recruitment. The UMOYA study will provide a unique platform to evaluate new emerging diagnostic tools and biomarkers for early diagnosis and treatment response and to investigate long-term outcomes of pulmonary TB and other respiratory events on lung health in children.